Method and device for skin treatment by muscle stimulation and pressure

ABSTRACT

A method and a system for skin treatment are presented. A muscle stimulating element is configured to provide muscle stimulation to a muscle layer located below the skin tissue, at least one pressure application element is configured to apply pressure on the skin tissue, a handheld applicator is configured to be placed in vicinity of the skin tissue to deliver said muscle stimulation from said muscle stimulating element and said pressure from said at least one pressure application element to one or more muscles in the muscle layer located below the skin tissue; and a control board is configured and operable to activate the muscle stimulating element and the at least one pressure application element according to one or more activation patterns adapted to provide one or more treatments to the skin tissue.

RELATED APPLICATIONS

This application is a continuation of and claims priority to U.S.application Ser. No. 16/907,252, filed Jun. 21, 2020, which is acontinuation of and claims priority to U.S. application Ser. No.15/587,487, filed May 5, 2017, now abandoned, which is a continuation ofand claims priority to U.S. application Ser. No. 13/510,062, filed May16, 2012, now abandoned, which is a U.S. National Stage application fromand claims priority to PCT Application No. PCT/IL2010/00947, filed Nov.16, 2010, which claims priority from U.S. provisional application No.61/261,381 filed on Nov. 16, 2009, all of which disclosures are hereinincorporated by reference.

FIELD OF THE INVENTION

The present invention relates generally to a device and method fortreating skin tissue by using a radio frequency (RF) generator combinedwith muscle stimulation (MS), including electrical muscle stimulation(EMS).

BACKGROUND OF THE INVENTION

Skin tissue comprises an outer epidermal layer overlaying a dermallayer. The dermal layer is in contact with a subcutaneous adipose layerreferred to as fatty tissue. Massaging the skin is known to improveblood circulation in the subcutaneous adipose tissue and help releasefat from the cells of the fatty tissue into the surrounding cellularmatrix. The fat is then removed by the body's lymphatic system.

U.S. Pat. No. 5,961,475 to Guitay discloses a massaging device in whichnegative pressure is applied to the user's skin while massaging. Thecombined treatment increases the blood circulation in the subcutaneousadipose tissue and breaks connections between adipose cells in thetissue.

U.S. Pat. No. 6,273,884 to Altshuler et al. discloses simultaneousapplication of optical energy and negative pressure to the user's skinfor treating skin defects.

There is however a need for improved methods to enhance the release offat from adipose tissue to increase lymphatic drainage.

SUMMARY OF THE INVENTION

An aspect of an embodiment of the invention, relates to an apparatus andmethod for accelerating lymphatic drainage. The method includes applyingRF energy to heat the adipose layer. Additionally the method includesmassaging the skin above the area that is heated by RF energy. Furtheradditionally the method includes electrical muscle stimulation (EMS) tocontract the muscles below the heated area thus providing pressure onthe adipose layer from below. The apparatus is designed to apply theabove three methods either separately or any combination of themsimultaneously: namely, massaging the skin from above, causingelectrical muscle stimulation from below, and heating the fatty tissuewith RF radiation.

In an exemplary embodiment of the invention, the RF energy is providedby a high frequency AC current, and the EMS energy is provided by a lowcurrent DC pulse signal. Optionally, the electrical energies (RF andEMS) are provided by a mono-polar configuration wherein the apparatusapplied to the user1s skin is provided with a first electrode of onepolarity, and a second electrode of the opposite polarity is attached tothe user or held by the user to form a closed circuit. Alternatively,the electrical energy may be provided by a bi-polar configurationwherein the apparatus applied to the user's skin includes two electrodesto form a closed circuit without attaching electrodes external to theapparatus to the body of the user. In some embodiments of the invention,the apparatus uses a multi-pole configuration wherein the apparatusincludes multiple electrodes of both poles of the circuit.

In some embodiments of the invention, some electrodes provide RF energyand other electrodes provide EMS energy. Alternatively, the sanleelectrodes are designed to synchronize the pulses and deliver any of thetwo currents by control of the apparatus.

In an exemplary embodiment of the invention, the skin massage may beperformed by applying positive pressure, for example in the form ofvibrations, pushing, pounding and the like. Alternatively oradditionally, the skin massage may be performed by applying negativepressure, for example using a vacuum or suction and the like.Optionally, the element of the apparatus applying the pressure may beheated or cooled while applying the pressure.

In an exemplary embodiment of the invention, when the apparatus isplaced m contact with the user 1s skin an electric circuit is formed andelectric current flows automatically from the electrode to the user.Optionally, the RF energy may be coordinated with the EMS energy so thatboth will be activated simultaneously or separately by control of theapparatus.

In an exemplary embodiment of the invention, the frequency of the RFenergy is selected to heat the user's skin mainly at the adipose layerpositioned under the apparatus. The EMS flow is designed to contract themuscles below the adipose layer causing pressure on the fatty cells frombelow.

In some embodiments of the invention, parameters related to the RFenergy are user selectable, for example signal intensity, frequency,duration and the like, to optimize usage of the apparatus for differentusers or different positions on the body of the user. Optionally, theparameters related to the EMS energy can be modified to fit the needs ofthe user, for example by selecting intensity, frequency, duration andthe like.

In some embodiments of the invention, parameters related to massagingthe skin are user selectable, for example the vibration rate, durationof vibrations, intensity, temperature of the massaging element and thelike. Alternatively, the massaging may be performed by manually pressingthe apparatus on the user's skin and moving it over a designated area.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will be understood and better appreciated from thefollowing detailed description taken in conjunction with the drawings.Identical structures, elements or parts, which appear in more than onefigure, are generally labeled with the same or similar number in all thefigures in which they appear, wherein:

FIG. 1 is a schematic illustration of a fat reduction device deployedupon a user's skin, according to an exemplary embodiment of theinvention;

FIG. 2 is a schematic illustration of liquefied fat exiting from fatcells into the extra cellular matrix responsive to the use of the fatreduction device, according to an exemplary embodiment of the invention;

FIG. 3 is a schematic illustration of a fat reduction device applying anelectrical current to stimulate a user's muscles, according to anexemplary embodiment of the invention;

FIG. 4 is a schematic illustration of a fat reduction device and theuser's skin following use of the fat reduction device, according to anexemplary embodiment of the invention;

FIG. 5 is a schematic block diagram of the elements of a fat reductiondevice, according to an exemplary embodiment of the invention; and

FIG. 6 is a schematic illustration of an RF signal combined with an EMSsignal, according to an exemplary embodiment of the invention.

DETAILED DESCRIPTION

FIG. 1 is a schematic illustration of a fat reduction device 110deployed upon a user's skin 120, according to an exemplary embodiment ofthe invention. The skin 120 includes an upper epidermal layer 160, alower dermal layer 170, and an adipose layer 140 (fat tissue layer).Muscles 150 are located below the adipose layer 140.

In an exemplary embodiment of the invention, fat reduction device 110includes one or more heads 115 that serve as massage contacts andoptionally also as electrodes for applying electrical energy.Optionally, fat reduction device 110 is adapted to perform at leastthree actions:

1. Massaging the outer layer of skin 120;

2. Heating the adipose layer 140 using RF energy 130 (e.g., with afrequency between 0.5 MHz to 2 MHz);

3. Stimulating the muscles 150 below the adipose layer 140 with anelectrical muscle stimulation (EMS) signal (e.g., with pulses of DCcurrent between +/−500 ma).

In an exemplary embodiment of the invention, fat reduction device 110 isdeployed upon the user's skin 120 and applies pressure with heads 115 tomassage the skin 120. Optionally the pressure may be in the form ofvibrations, pushing, pounding, or other tactile forms. Alternatively, oradditionally, the massaging may be in a negative form, for example byapplying a vacuum or suction or similar form. FIG. 1 demonstrates howthe skin 120 takes an uneven form due to the physical pressure exeliedupon it. In some embodiments of the invention, fat reduction device 110includes an element that applies the pressure, for example a motor apiezoelectric chip or other devices known in the art. Alternatively, thepressure may be exerted by manually pressing heads 115 against theuser's skin.

In an exemplary embodiment of the invention, the RF energy 130 isdelivered through the skin to the adipose layer 140. The RF energy 130accelerates natural fat cell metabolism causing the release of liquefiedfat from the cells into the extra cellular matrix. Additionally, the RFenergy 130 heats collagen fibers and stimulates fibroblast metabolismresulting in tightening of the skin 120 and an increase in new collagenproduction.

Optionally, the physical pressure loosens the ties between the fat cellsand together with the heating from the RF energy 130 accelerates releaseof liquefied fat from the fat cells. The heating and massaging alsoincrease blood flow thus providing more nourishment to the area andremoving dead cells and other impurities at all increased rate.

FIG. 2 is a schematic illustration of liquefied fat 220 exiting from fatcells 210 into the extra cellular matrix responsive to the use of thefat reduction device 110, according to an exemplary embodiment of theinvention. In an exemplary embodiment of the invention, the RF energy isset to heat the fat cells 210 to a level wherein the temperature on thesurface of the skin does not exceed 40° C.-45° C. to prevent skindamage. Optionally, higher temperature ranges may be possible for shortdurations.

FIG. 3 is a schematic illustration of fat reduction device 110 applyingan electrical current 310 to stimulate the user's muscles 150, accordingto an exemplary embodiment of the invention. In an exemplary embodimentof the invention, electrical current 310 from the electrical musclestimulation (EMS) pulse causes the muscles 150 to contract below theadipose layer 140, which causes a dual force to be applied to the fatcells 210. From above the adipose layer 140 is pressured physically byfat reduction device 110 and from below the EMS signals cause themuscles 150 to exert pressure on adipose layer 140. In some embodimentsof the invention, the RF energy 130 and/or the EMS pulse may beactivated by an activation switch on fat reduction device 110.Alternatively, they may be activated upon contact with the user's skin,for example by closing a circuit through the user's skin or by applyingpressure on the head of fat reduction device 110.

FIG. 4 is a schematic illustration of fat reduction device 110 and theuser's skin 120 following use of fat reduction device 110, according toan exemplary embodiment of the invention. Optionally, after applying fatreduction device 110 the distance between the muscles 150 and theepidermal layer 160 is reduced due to the exit of liquefied fat from thefat cells 210 of the adipose layer 140. Additionally, the epidermallayer 160 becomes smoother due to the tightening resulting from thecollagen production as described above.

FIG. 5 is a schematic block diagram of the elements of fat reductiondevice 110, according to an exemplary embodiment of the invention. In anexemplary embodiment of the invention, fat reduction device 110 includesan RF generator 510 to provide an AC current in the form of a radiofrequency (RF) electrical pulse for heating the user's skin 120.Optionally the AC signal is a low current signal, for example of about1-10 ma, 24 VAC with a frequency between 0.5 MHz-2 MHz to prevent damageto the user's skin 120. In an exemplary embodiment of the invention, fatreduction device 110 also includes an electric pulse (EP) generator 520that provides low current DC pulse signals, for example between +500 mato −500 ma to cause the muscles 150 to expand and contract. In anexemplary embodiment of the invention, fat reduction device 110 includesa control board 530 that determines the actions of the device.Optionally, control board 530 may be a general purpose computer or adedicated circuit. Control board 530 controls the duration, intensity,frequency and any other parameters of the electric pulses of theelectrical current 310 for stimulating the muscles 150, and the RFenergy 130 for heating the adipose layer 140. Additionally, the controlboard 530 determines the timing for applying the EP signal and the RFsignal. In some embodiments of the invention, control board 530 includesa CPU, a memory, and input/output devices, for example a keypad and ascreen.

In some embodiments of the invention, the control board acceptsmeasurements from various sensors and controls fat reduction device 110responsive to the measurements, for example temperature readings from atemperature sensor 550, which may include a thermistor or thermocouplemonitoring the skin temperature. Optionally, the sensors may be placedin head 115, for example adjacent to the electrodes.

In a . . . 11 exemplary embodiment of the invention, fat reductiondevice 110 includes an applicator 540 for applying the actions describedabove. In an exemplary embodiment of the invention, fat reduction device110 is fed from a power source 590. Optionally, the power source 590 maybe an internal power source, for example a battery. Alternatively, powersource 590 may be an external power source, for example by connecting apower cable to a standard household power outlet.

In an exemplary embodiment of the invention, applicator 540 includes oneor more heads 115 that serve as massage contacts 560, and electrodes570. In some embodiments of the invention, the applicator may include anactivation switch 580 to turn on and off fat reduction device 110,Optionally, activation switch 580 may be independently controlled by theuser or may be automatically controlled, for example by placing fatreduction device 110 in contact with the user1s body so that an electriccircuit is formed or by pressing the fat reduction device 110 againstthe user's body causing the activation switch 580 to be depressed.

In some embodiments of the invention, fat reduction device 110 may use amono-polar configuration wherein one pole of the circuit is representedby one or more electrodes on heads 115 and placed in contact with theuser's skin. Optionally, the opposite pole is placed as a patch on theuser's body or on a handle for grasping fat reduction device 110, toform a closed circuit. Alternatively, fat reduction device 110 may use abi-polar configuration wherein both poles are represented by electrodeson the head 115 of the device, and no external electrodes are required.In some embodiments of the invention, a multi-polar configuration isused, with multiple electrodes wherein some of the electrodes on head115 represent a first pole of the circuit and some represent theopposite pole. Optionally, the polarity of the electrodes may becontrolled by control board 530, and their polarity may alternate duringuse of fat reduction device 110.

In some embodiments of the invention, some of the electrodes deliver RFenergy 130 and some deliver electrical current 310. Alternatively, thesame electrodes may deliver RF energy 130 and electrical current 310intermittently. In some embodiments of the invention, electrical current310 from the electrical muscle stimulation (EMS) signal is appliedindependent of the RF energy signal 130.

In an exemplary embodiment of the invention, control 530 controls theactions of the massage contacts 560. Optionally, the massage contacts560 may include a motor, a piezoelectric element, a suction, a vacuum orother devices to massage the user's skin either positively ornegatively. In an exemplary embodiment of the invention, the action ofmassage contacts 560 are synchronized with the electrical musclestimulation (EMS) so that the adipose layer will be pressurized on bothsides simultaneously. Alternatively, each function may actindependently. In some embodiments of the invention, the massage isapplied manually by pressing massage contacts 560 against the user'sskin 120, and optionally moving them back and forth across the user'sskin 120. Optionally, massage contacts 560 may be made from a softmaterial or hard material selected for providing a comfortable feelingto the user while massaging the user's skin 120. In some embodiments ofthe invention, the massage contacts 560 may include a heater to warm thecontacts to enhance comfort and/or effectiveness of the massage.

FIG. 6 is a schematic illustration of an RF energy signal synchronizedwith an EMS signal, according to an exemplary embodiment of theinvention. In an exemplary embodiment of the invention, an electricpulse 610 of for example 100 micro-seconds is provide during an intervalof 1 ms after which a RF energy signal 620 is applied, for example for aduration of 9 ms. This sequence is applied repetitively while the fatreduction device is activated. Optionally, other duration may be used,for example the duration of electric pulse 610 may be longer than theduration of RF radiation signal 620 or vice versa.

It should be appreciated that the above-described methods and apparatusmay be varied in many ways, including omitting or adding steps, changingthe order of steps and the type of devices used. It should beappreciated that different features may be combined in different ways.In particular, not all the features shown above in a particularembodiment are necessary in every embodiment of the invention. Furthercombinations of the above features are also considered to be within thescope of some embodiments of the invention.

It will be appreciated by persons skilled in the art that the presentinvention is not limited to what has been particularly shown anddescribed hereinabove. Rather the scope of the present invention isdefined only by the claims, which follow.

1. A method of treating a person's skin tissue, comprising: providing askin tissue treatment apparatus comprising: a muscle stimulating elementconfigured to provide muscle stimulation to a muscle layer located belowthe skin tissue, at least one pressure application element configured toapply pressure on the skin tissue, a handheld applicator configured tobe placed in vicinity of the skin tissue to deliver said musclestimulation from said muscle stimulating element and said pressure fromsaid at least one pressure application element to one or more muscles inthe muscle layer located below the skin tissue; and providing a controlboard configured and operable to activate the muscle stimulating elementand the at least one pressure application element according to one ormore activation patterns adapted to provide one or more treatments tothe skin tissue.
 2. The method according to claim 1, wherein said one ormore treatments to the skin tissue comprise one or more of thefollowing: skin tightening, reducing distance between epidermis layerand the muscle layer, fibroblast metabolism and/or collagen productionin a skin layer above the muscle layer.
 3. The method according to claim1, wherein said at least one pressure application element is configuredto apply at least one of positive and negative pressure on the skintissue.
 4. The method according to claim 1, wherein said handheldapplicator comprises one or more heads configured to contact the skintissue during said one or more treatments.
 5. The method according toclaim 4, wherein said at least one pressure application element isformed by at least one of said one or more heads, the pressureapplication element is configured to apply a positive pressure to theskin tissue by manually moving said handheld applicator over the skintissue.
 6. The method according to claim 4, wherein said pressureapplication element is configured to apply a positive pressure to theskin tissue by one or more of the following: vibrating, pushing, andpounding at least one of said one or more heads.
 7. The method accordingto claim 3, wherein said at least one pressure application elementcomprises a vacuum source configured to apply the negative pressure bysuction to the skin tissue.
 8. The method according to claim 1, whereinsaid at least one pressure application element is configured to applyboth positive and negative pressure to the skin tissue, said controlboard is configured to activate the muscle stimulating element toprovide pulses of muscle stimulation signals to the skin tissue, said atleast one pressure application element being activated to apply thepositive pressure simultaneously with the pulses of the musclestimulation signals and to apply the negative pressure during intervalsbetween the pulses of the muscle stimulation signals.
 9. The methodaccording to claim 4, wherein said one or more heads comprise one ormore electrodes in electrical communication with said muscle stimulatingelement, wherein said muscle stimulating element comprises an electricalpulse generator configured to provide electrical muscle stimulationsignal (EMS) to the one or more muscles in the muscle layer locatedbelow the skin tissue, and wherein said one or more electrodes areconfigured to deliver the electrical muscle stimulation signal to theskin tissue.
 10. The method according to claim 9, wherein saidactivation pattern of said EMS is user selectable and includes one ormore of the following: signal intensity, frequency, and duration,thereby enabling to optimize the one or more treatments for differentusers or different positions on body of the treated person.
 11. Themethod according to claim 1, wherein said control board is configuredand operable to activate said muscle stimulation and pressureapplication in one or more of the following activation patterns:sequentially, intermittently and simultaneously, to thereby providemuscle stimulation flow and cause selective contraction and expansion ofthe one or more muscles in the muscle layer located below the skintissue.
 12. A system of treating a person's skin tissue, comprising: askin tissue treatment apparatus comprising: a muscle stimulating elementconfigured to provide muscle stimulation to a muscle layer located belowthe skin tissue, at least one pressure application element configured toapply pressure on the skin tissue, a handheld applicator configured tobe placed in vicinity of the skin tissue to deliver said musclestimulation from said muscle stimulating element and said pressure fromsaid at least one pressure application element to one or more muscles inthe muscle layer located below the skin tissue; and a control boardconfigured and operable to activate the muscle stimulating element andthe at least one pressure application element according to one or moreactivation patterns adapted to provide one or more treatments to theskin tissue.
 13. The system according to claim 13, wherein said one ormore treatments to the skin tissue comprise one or more of thefollowing: skin tightening, reducing distance between epidermis layerand the muscle layer, fibroblast metabolism and/or collagen productionin a skin layer above the muscle layer.
 14. The system according toclaim 12, wherein said at least one pressure application element isconfigured to apply at least one of positive and negative pressure onthe skin tissue.
 15. The method according to claim 12, wherein saidhandheld applicator comprises one or more heads configured to contactthe skin tissue during said one or more treatments.
 16. The systemaccording to claim 15, wherein said at least one pressure applicationelement is formed by at least one of said one or more heads, thepressure application element is configured to apply a positive pressureto the skin tissue by manually moving said handheld applicator over theskin tissue.
 17. The system according to claim 15, wherein said pressureapplication element is configured to apply a positive pressure to theskin tissue by one or more of the following: vibrating, pushing, andpounding at least one of said one or more heads.
 18. The methodaccording to claim 14, wherein said at least one pressure applicationelement comprises a vacuum source configured to apply the negativepressure by suction to the skin tissue.
 19. The system according toclaim 12, wherein said at least one pressure application element isconfigured to apply both positive and negative pressure to the skintissue, said control board is configured to activate the musclestimulating element to provide pulses of muscle stimulation signals tothe skin tissue, said at least one pressure application element beingactivated to apply the positive pressure simultaneously with the pulsesof the muscle stimulation signals and to apply the negative pressureduring intervals between the pulses of the muscle stimulation signals.20. The system according to claim 15, wherein said one or more headscomprise one or more electrodes in electrical communication with saidmuscle stimulating element, wherein said muscle stimulating elementcomprises an electrical pulse generator configured to provide electricalmuscle stimulation signal (EMS) to the one or more muscles in the musclelayer located below the skin tissue, and wherein said one or moreelectrodes are configured to deliver the electrical muscle stimulationsignal to the skin tissue.
 21. The system according to claim 12, whereinsaid control board is configured and operable to activate said musclestimulation and pressure application in one or more of the followingactivation patterns: sequentially, intermittently and simultaneously, tothereby provide muscle stimulation flow and cause selective contractionand expansion of the one or more muscles in the muscle layer locatedbelow the skin tissue.